4 ms·

The Special Order might be of the "we're looking for a justification to fine you and issue a recall" type, which it looks like they often are.

ubernostrum 10y ago
Typically when you get to the point of getting one of those it's because you've been blatantly ignoring regulations or regulators up until now and they feel like they need to get your attention.
EpicEng 10y ago
Well if they were planning on going to market without being able to pass an audit then they deserve every bit of it. I've worked in am FDA regulated field for a little over a decade and getting in touch with regulatory bodies up front is par for the course. Sounds to me like they don't know what they're doing and are in over their heads.
deleted 10y ago
[deleted]
tptacek 10y ago
People have a lot of theories about what this letter meant, but the people on HN who have actually worked with NHTSA orders say the order means just what it says it means, and that NHTSA is pretty reasonable to work with. Certainly the questions in the order --- I posted them on the first thread about the comma one --- seemed pretty basic and reasonable.
- shadowshadow 10y ago
  The questions were reasonable, but the cover letter was very negative. Could you point me to comments with first hand NHTSA experience? I didn't see any.
  - tptacek 10y ago
    The cover letter was very "do not blow off the NHTSA". One commenter who had experience with NHTSA provided examples of orders they sent other companies with similar language.
    - shadowshadow 10y ago
      I assume you mean this comment? https://news.ycombinator.com/item?id=12819423 https://news.ycombinator.com/item?id=12819423 The listed special orders were the pretext to $70m, $35m and $105m fines. Doesn't inspire confidence. It might just be reporting bias, but I couldn't find an example of a special order that wasn't associated with a massive scandal.
      - jacquesm 10y ago
        The idea is that you comply with the request, not ignore it. Those fines only kick in if you decide to go ahead anyway.

ubernostrum 10y ago

Typically when you get to the point of getting one of those it's because you've been blatantly ignoring regulations or regulators up until now and they feel like they need to get your attention.

EpicEng 10y ago

Well if they were planning on going to market without being able to pass an audit then they deserve every bit of it. I've worked in am FDA regulated field for a little over a decade and getting in touch with regulatory bodies up front is par for the course. Sounds to me like they don't know what they're doing and are in over their heads.

deleted 10y ago

[deleted]

tptacek 10y ago

People have a lot of theories about what this letter meant, but the people on HN who have actually worked with NHTSA orders say the order means just what it says it means, and that NHTSA is pretty reasonable to work with. Certainly the questions in the order --- I posted them on the first thread about the comma one --- seemed pretty basic and reasonable.

shadowshadow 10y ago
The questions were reasonable, but the cover letter was very negative. Could you point me to comments with first hand NHTSA experience? I didn't see any.
- tptacek 10y ago
  The cover letter was very "do not blow off the NHTSA". One commenter who had experience with NHTSA provided examples of orders they sent other companies with similar language.
  - shadowshadow 10y ago
    I assume you mean this comment? https://news.ycombinator.com/item?id=12819423 https://news.ycombinator.com/item?id=12819423 The listed special orders were the pretext to $70m, $35m and $105m fines. Doesn't inspire confidence. It might just be reporting bias, but I couldn't find an example of a special order that wasn't associated with a massive scandal.
    - jacquesm 10y ago
      The idea is that you comply with the request, not ignore it. Those fines only kick in if you decide to go ahead anyway.